To demonstrate that removal of drains exclusively based on digital drainage system data is non-inferior to additional clamping trials regarding recurrent pneumothorax requiring chest tube reinsertion.
ID
Source
Brief title
Condition
- Pleural disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: recurrent pneumothorax after chest tube removal
requiring chest tube reinsertion.
Secondary outcome
Secondary outcome measures: hospital length of stay, recurrent intervention,
number of additional imaging studies, and pneumothorax or subcutaneous
emphysema; not requiring chest tube reinsertion.
Background summary
Determining and timing of chest tube removal has been a continuous topic of
debate amongst both surgeons and pulmonologist. It is plausible that
provocative clamping tests are no longer necessary when a digital continuous
recording drainage device is used that demonstrates the absence of
(intermittent) air leak. However, clamping trials are still performed in
clinical care, it is an expert opinion*s policy prompted by fear of recurrent
pneumothorax and no comparative studies exist. We hypothesize that chest tube
removal exclusively based on digital drainage system data is as safe as adding
a clamping test before removal in patients treated for pneumothorax or after
lung surgery.
Study objective
To demonstrate that removal of drains exclusively based on digital drainage
system data is non-inferior to additional clamping trials regarding recurrent
pneumothorax requiring chest tube reinsertion.
Study design
The study will be conducted as a, prospective, open label, non-inferiority,
randomized controlled trial.
Intervention
In the intervention group; chest tube removal will be determined by air flow
criteria as indicated by the digital drainage system data. In the control group
removal will be determined by the same criteria of the digital drainage system
but before removal, a chest tube clamping test will be performed.
Study burden and risks
Procedures as described for the study groups are both used in clinical care,
therefore the risks and burden associated with participation is comparable to
the standard of care. Digital drainage systems result in less complications
after chest tube removal than analogue drainage systems. Clamping trials,
although having small but implicit risk of tension pneumothorax, leave the
possibility to open the air drain immediately by removing the clamps. Removing
the drain based on digital leakage data might shorten drainage time but
requires a new drain when the lung collapses with symptoms. As both courses are
used in clinical practice, clarity about the optimal approach is desirable and
justifies a prospective randomised trial. Possible benefit will be shorter
chest tube duration.
dr. van Heesweg 2
Zwolle 8025AB
NL
dr. van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
- Digital chest tube drainage system
- Pneumothorax (primary, secondary, pulmonary surgery)
Exclusion criteria
• Pleural effusion as primary indication for chest tube placement.
• Empyema
• Suspected chest tube malfunction (e.g., leaking, occlusion, malposition)
• Intubated during chest tube removal
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05180955 |
| CCMO | NL81018.075.22 |